e-Mobile Tablet for People With Chronic Conditions

Examining the Usability of Computer Tablets to Promote Symptom Self-management and Engagement in Healthy Behaviors in Adults With Chronic Conditions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02833311

Enrollment

Registered

2016-07-14

Start date

2013-11-30

Completion date

2016-04-30

Last updated

2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Multiple Sclerosis, Osteoarthritis, Parkinson's Disease, Sjögren's Syndrome

Keywords

Neuromusculoskeletal condition

Brief summary

Maintaining a healthy diet and engaging in routine physical activity may help decrease severity of symptoms, prevent secondary conditions, and slow functional decline in people with disabling neuromusculoskeletal conditions. However, people with these conditions face many health barriers to engaging in healthy behaviors. With the advent of portable technologies, such as smart phones, tablets and PDAs, there is a need to explore whether these technologies can help people with disabling conditions to stay motivated and overcome barriers to engaging in healthy behaviors.

Detailed description

The overarching goal of this mixed methods, comparative effectiveness randomized controlled pilot study is to evaluate whether goal setting, self-monitoring, and barrier management using a computer tablet can increase physical activity behavior, improve nutritional habits, and promote health-related quality of life in people with disabling neuromusculoskeletal conditions. Our hypothesis is that, in comparison to the standard care contact control group, participants in both the tablet group and the paper and pencil group will yield significant improvements in healthy behaviors,with the tablet group yielding significantly larger increases.

Interventions

BEHAVIORALComputer Tablet Group

A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.

BEHAVIORALPaper and Pencil Group

Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.

BEHAVIORALContact Control Group

Participants are prescribed an exercise program and given information on healthy eating.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 76 Years

Healthy volunteers

Inclusion criteria

* Physician-confirmed diagnosis of a neuro-musculoskeletal condition or disease of the nerves, muscles, and/or bones that results in functional limitations * Physician consent to engage in home exercise/physical activity program * Regularly inactive (i.e., engaging in 90 minutes or less of purposeful physical activity each week) * Scoring ≤17 mental composite and ≤16 physical composite on the Global Health Questionnaire. * Have internet access (i.e., home, library or other WiFi location)

Exclusion criteria

* If the only disabling condition reported is not considered a neuro-musculoskeletal disease * Have hand-motor function impairments that would limit use of the tablet * Often engage in healthy eating habits * Are frequent fallers (i.e., more than 3 falls per month) * Have a diagnoses of chronic obstructive pulmonary disease, serious mental health disorder, chronic heart failure, myocardial infarction, and other unstable/severe cardiovascular conditions, and uncontrolled diabetes mellitus (e.g., admission to the hospital within the past 6 months for uncontrolled diabetes) * Have severe cognitive deficits * Reports consistently tracking and monitoring health behaviors * Unable to effectively use the tablet technology during the pre-intervention usability demonstration

Design outcomes

Primary

Measure	Time frame	Description
Changes From Baseline in Physical Activity	Outcomes were administered immediately before the intervention and again 6-weeks later	Physical Activity and Disability Survey-Revised was administered to assess physical activity behavior. Scores can range from -2.7493 to 3.3671. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels.

Secondary

Measure	Time frame	Description
Changes From Baseline in Self-Report Physical Function	Outcomes were administered immediately before the intervention and again 6-weeks later	Patient Reported Outcome Measurement information System (PROMIS) Physical Function (PF) was used to measure self-report physical function. Measures are scored on a T-score metric. High scores indicate more of the concept being measured. A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Changes From Baseline in 6-minute Walking Test	Outcomes were administered immediately before the intervention and again 6-weeks later	—
Changes From Baseline in Self-Efficacy	Outcomes were administered immediately before the intervention and again 6-weeks later	Exercise Confidence Survey was used to measure self-efficacy. The survey asks about confidence in sticking to an exercise program and making time for exercise. This is a 12 item questionnaire and scores ranges from 1 to 60. A higher score indicates increased confidence to engage in exercise.
Changes From Baseline in Weight	Outcomes were administered immediately before the intervention and again 6-weeks later	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Computer Tablet Group A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom. Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.	15
Paper and Pencil Group Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.	16
Standard Treatment Control Group Participants are prescribed an exercise program and given information on healthy eating. Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.	15
Total	46

Baseline characteristics

Characteristic	Paper and Pencil Group	Standard Treatment Control Group	Computer Tablet Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	5 Participants	4 Participants	1 Participants	10 Participants
Age, Categorical Between 18 and 65 years	11 Participants	11 Participants	14 Participants	36 Participants
Age, Continuous	59.38 years STANDARD_DEVIATION 10.2	55 years STANDARD_DEVIATION 11.58	58.93 years STANDARD_DEVIATION 5.52	57.8 years STANDARD_DEVIATION 9.48
Region of Enrollment United States	16 participants	15 participants	15 participants	46 participants
Sex: Female, Male Female	14 Participants	12 Participants	13 Participants	39 Participants
Sex: Female, Male Male	2 Participants	3 Participants	2 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 15	0 / 16	0 / 15
serious Total, serious adverse events	3 / 15	3 / 16	1 / 15

Outcome results

Primary

Changes From Baseline in Physical Activity

Physical Activity and Disability Survey-Revised was administered to assess physical activity behavior. Scores can range from -2.7493 to 3.3671. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels.